Duns Number:076594100
Device Description: Blood Volume Monitor
Catalog Number
-
Brand Name
Crit-Line®
Version/Model Number
CL10051001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141997
Product Code
KOC
Product Code Name
ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
Public Device Record Key
a5bfa337-76f7-4a5d-a0ee-d6b50aa35ac2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |